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Biomanufacturing Regulatory Affairs Specialist_

3 months ago


San Antonio, United States Insight Global Full time

Job Description A company based in San Antonio; TX is seeking a Regulatory Affairs Specialist to join their team. The role involves overseeing the Regulatory Affairs aspect of the team's activities, ensuring adherence to compliance throughout the biomanufacturing process. This role will be instrumental in identifying areas for continuous process improvement, ensuring compliance with different regulation agencies. Salary for this position ranges from $90-$120,000. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: om/workforce-privacy-policy/ . Skills and Requirements - Bachelor's degree in applied science - A minimum of 5 years of supporting regulatory agencies such as the FDA, EU, and ISO - Experience with regulatory compliance and quality assurance within biomanufacturing - Master's degree - Aseptic Biologics, clean room experience - Master Control Experience null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.